Quality Assurance Director

Qualitas; Manchester; Remote; GBP 70,000 - 90,000; Full time

Job summary

A leading international CRO in the UK is seeking a remote Quality Assurance Director. This role involves overseeing the QA services, managing a team, and ensuring compliance with regulations. Ideal candidates will have a degree in Life Sciences and substantial experience in Quality Assurance and leadership. This opportunity allows for the growth of both the department and the individual in a dynamic environment.

Qualifications

• At least 8 years of relevant work experience in Quality Assurance.
• 3-4 years minimum of leadership/management experience.
• Demonstrable experience growing a Profit and Loss.

Responsibilities

• Oversee the design and delivery of QA services.
• Ensure regulatory compliance and operational excellence.
• Manage QAS project portfolio and its risk.

Skills

Leadership

Regulatory compliance knowledge

Auditing

Risk management

Education

Bachelor's degree in Life Sciences

Job description

Overview

Qualitas is partnered exclusively with a leading international CRO who specialise in Pharmacovigilance, Quality Assurance, Clinical, and Consulting services to global Pharmaceutical and Biotech companies. They are seeking a remote Quality Assurance Director to lead and expand Quality Assurance services while leading and developing a team of QA professionals nationally and internationally.

Responsibilities

• Oversee the design, delivery, and continuous improvement of QA services across client engagements, ensuring regulatory compliance, operational excellence, and customer satisfaction.
• Ensure day-to-day activities of the QA Services team.
• Develop workflow and operational planning for QA Services, overseeing the delivery of all projects within the department.
• Manage the QAS project portfolio and its risk.
• Ensure department profitability through efficient resource allocation and billability.
• Work closely with the Business Development team to grow QA Services, helping to develop plans for expanding the client base and services offered.
• Ensure clients receive the requested services, guaranteeing the quality of the project delivery within the agreed budget and timelines.
• Participate in client meetings as required and oversee all customer proposals.
• Ensure that Quality & Projects Plans are developed according to client requirements.
• Ensure tracking of all relevant compliance metrics.
• Identify successful drivers for defining and managing KPIs for strategic processes to guarantee continuous improvement of QAS services.
• Where necessary, prepare and perform audits on behalf of clients, and relevant reporting to them.
• Manage external auditors and engage them as appropriate.
• Escalate to the MD of Services and relevant CALS any Critical Risks for client relationships.
• Contribute to and ensure optimal public relations activities and brand awareness.
• Assess customers' feedback and make necessary improvements.
• Ensure that department processes are efficient and cost-effective.
• Guarantee compliance with current regulations.

Knowledge and Experience Required

• Bachelor's degree in Life Sciences/Scientific matters.
• At least 8 years of relevant work experience in Quality Assurance.
• 3-4 years minimum of leadership/management experience.
• Demonstrable experience of growing a Profit and Loss through delivery and client relationships.
• Fluent in English.
• Excellent knowledge in either GCP, GLP or GMP regulations.
• Auditing experience.
• Essential regulatory guidelines worldwide.

The company are happy for Managers/Snr Manager to apply who are looking for a step up or someone who is already at this level.

Please apply if you are interested in this exiting opportunity